BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    MCS 50MO X-RAY TUBE INSERT/MXS 50MO TUBE HOU ASSEM

    K Number: K913301 · Decision Aug 28, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    54
    Registration Numbers
    54
    Same Product Code
    39
    Applicant Total
    1
    Review Days
    34

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    MCS 50MO X-RAY TUBE INSERT/MXS 50MO TUBE HOU ASSEM
    K Number
    K913301
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    892.1760
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Comet North America, Inc.
    Date Received
    July 25, 1991
    Decision Date
    August 28, 1991
    Product Code
    ITY
    Advisory Committee
    Radiology
    Review Advisory Committee
    RA
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    ITY Assembly, Tube Housing, X-Ray, Diagnostic

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (ITY), ordered by most recent decision date.

    X-RAY MONOBLOCK, MONOBLOCK XRS-60-330

    FDA 510(k)
    FDA Class 1 ·Radiology

    MRX-750

    FDA 510(k)
    FDA Class 1 ·Radiology

    MOLYBDENUM

    FDA 510(k)
    FDA Class 1 ·Radiology

    PHILIPS PRE-FILTER OPTION

    FDA 510(k)
    FDA Class 1 ·Radiology

    MRX-700

    FDA 510(k)
    FDA Class 1 ·Radiology

    MRX-865

    FDA 510(k)
    FDA Class 1 ·Radiology
    View all